亲和生物制剂/止血控制血浆(高水平异常)/VisuCon-L Coag屏幕异常2在体外被FDA、加拿大卫生部和CE标记的诊断用途清除。可在美国、加拿大和部分欧洲国家销售

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货号:VisuCon-LCoagScreenAbnormal2isclearedfo
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品牌:affinity
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Description

Hemostasis Control Plasma – High-Level Abnormal

The VisuCon-L Coag Screen Abnormal 2 is a Hemostasis Control Plasma (High-Level Abnormal) that can be used in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated partial thromboplastin time (APTT), in the highly abnormal range.  The VisuCon-L Coag Screen ABN plasmas may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.  Good laboratory practice requires that assays be calibrated over the relevant range and that controls be performed regularly to confirm assay calibration.  This plasma is citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer, as well as stabilizing agents, dispensed and lyophilized.

VisuCon-L Coag Screen Abnormal 2 is cleared for in vitro Diagnostic use by FDA, Health Canada and CE marked.  Available for sale in the United States, Canada and select European countries. 

  • Box containing 10 x 1 mL vials of lyophilized Hemostasis Control Plasma (High-Level Abnormal), Prod. # LCSAB201

The results obtained with the VisuCon-L Coag Screen ABN plasmas will be subject to the limitations of the assay system including types of reagents and instrumentation.

Preparation/Handling:

Reconstitute each vial with 1 ml reagent grade water. Swirl gently and let stand for 15 minutes. Swirl gently once more before using this Hemostasis Control Plasma (High-Level Abnormal).

Storage and Stability:

Vials are stable until the expiration date stated on the vial when stored at 2 – 8°C. Once reconstituted, the plasma is stable for 24 hours on-board (15 – 22°C) or at 2 – 8°C in original vial. Gently mix vial of plasma if left for more than 2 hours without use. Reconstituted material should be discarded after use and not be refrozen.

Assay Procedure:

After reconstituting the VisuCon-L Coag Screen ABN plasmas, use on coagulation instrument or assay system with corresponding reagents in accordance with established coagulation assay procedures. If appropriate control values are not obtained, assess the components of the assay system including reagents, substrate plasmas, calibrator plasma or instrumentation to try and identify potential sources of error.

Product Datasheet: VisuCon-L Coag Screen ABN1 - Freeze Dried High-Level Abnormal Plasma


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